Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the ...

Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% ...

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...

Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental ...

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...

Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.

On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.

A third fatality has been recorded among patients receiving treatment with a Sarepta gene therapy, adding to the troubles ...